SBS - The best value in QMS software

The refund of 510(k) user fee

Ashley Fu

Starting to get Involved
#1
According to FAQ 14 in the guidance "a User Fees and Refunds for Premarket Notification Submissions (510(k)s)" , If eligible,
we just need to submit a written request to the appropriate Center in FDA to request a refund no later than 180 days after the fee was due.

It seems the process of the refund is not complex. :applause:
But is there any information required in the written request? Does it need to explain the backgrounds specificly about the refund?

Did someone have successfully got the refundment from FDA?It's the first time I encounter the situation.


Any comments will be much appreciated!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
W Construction Contingency Refund? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N Replace, Repair, or Refund - Customer's Demand ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
S Predicate Material 510(k) US Food and Drug Administration (FDA) 0
S Predicate Material 510(k) Medical Device and FDA Regulations and Standards News 3
J US Device Listing when not the 510(k) owner Medical Device and FDA Regulations and Standards News 2
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
S Special 510(k) for orthopedic implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Label change - 510(k) Medical Device and FDA Regulations and Standards News 5
G We want to add Covid-2 /19 to our air filter 510 K Medical Device and FDA Regulations and Standards News 0
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
A 510(k) review timeline 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Impact on 510(k) to use an additional manufacture US Food and Drug Administration (FDA) 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
Watchcat Advantages to pursuing a Special 510(k) instead of a Traditional 510(k) Other US Medical Device Regulations 5
A 510(k) registration and listing US Food and Drug Administration (FDA) 1
Aymaneh Traditional 510(k) Declaration of Conformity Other Medical Device Regulations World-Wide 3
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
A Some doubts about traditional 510(k) submission US Food and Drug Administration (FDA) 5
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Y Expanding the indications for use for a 510(k) cleared device Medical Device and FDA Regulations and Standards News 5
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 4
T Submitting MR Compatibility Data for 510(k) Cleared Device Other Medical Device and Orthopedic Related Topics 2
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
K 510(K) File eCopy Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
D Redacted 510(k)s - Example wanted Document Control Systems, Procedures, Forms and Templates 14
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Completing Design Controls after 510(k) Clearance Other US Medical Device Regulations 11
P Predicate Device Information for 510(k) Submission Medical Device and FDA Regulations and Standards News 4
M 510(k) 10993 Biocompability Testing Other US Medical Device Regulations 15
D First 510(k) Submission - Don't Forget Tips US Food and Drug Administration (FDA) 5
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
K Mammography Machine Bench Testing - FDA 510(K) US Food and Drug Administration (FDA) 5
D Is Human Factors testing mandatory for a 510(k) submission? Human Factors and Ergonomics in Engineering 16
D Pre-Submission after 510(K) Submission? Other US Medical Device Regulations 4
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
M CBE (Change Being Effected) 510(k) Submission Other US Medical Device Regulations 2
K 510(K) Submission (Traditional) for Medical Device US Food and Drug Administration (FDA) 15
F Replacement Bone Screws - Traditional 510(k) or Special 510(k)? Other US Medical Device Regulations 7
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
Watchcat Informational FDA Proposal to "Modernize" the 510(k) - 2019 Other US Medical Device Regulations 1
B 510(k) clearance claim on medical device product packaging Other US Medical Device Regulations 6
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
B Submit a 510(k) with a Predicate cleared but not Listed US Food and Drug Administration (FDA) 9

Similar threads

Top Bottom